Phase 3 N=1,473 Randomized Prevention

Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

Bacterial Infections · Virus Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01337167 ↗

Enrolled (actual)

1,473

Serious AEs

6.2%

Results posted

Mar 2016

Primary outcome: Primary: Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen — 84.97; 75.39; 97.25; 92.41 Percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: V419 (Biological); DAPTACEL™ (Biological); PedvaxHIB™ (Biological); Prevnar 13™ (Biological); RotaTeq™ (Biological); PENTACEL™ (Biological); Recombivax HB vaccine (Biological); ActHIB™ (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	84.97; 75.39; 97.25; 92.41	<0.001 sig
PRIMARY Percentage of Participants Responding to Hepatitis B Surface Antigen	99.42; 98.58	<0.001 sig
PRIMARY Percentage of Participants Responding to Diphtheria Toxin	82.44; 86.26	0.002 sig
PRIMARY Percentage of Participants Responding to Tetanus Toxin	99.87; 99.49	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Toxin	99.29; 97.42	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	94.42; 93.14	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Pertactin	93.01; 93.45	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Fimbriae	97.29; 91.17	<0.001 sig
PRIMARY Percentage of Participants Responding to Poliovirus Type 1	100.00; 98.24	<0.001 sig
PRIMARY Percentage of Participants Responding to Poliovirus Type 2	100.00; 99.75	<0.001 sig
PRIMARY Percentage of Participants Responding to Poliovirus Type 3	100.00; 99.75	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Toxin	127.22; 91.31	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	88.92; 89.18	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Pertactin	108.05; 139.35	0.014 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	658.50; 414.66	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Toxin	99.29; 97.42	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	94.42; 93.14	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Pertactin	93.01; 93.45	<0.001 sig
PRIMARY Percentage of Participants Responding to Pertussis Fimbriae	97.29; 91.17	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Toxin	127.22; 91.31	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	88.92; 89.18	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Pertactin	108.05; 139.35	0.014 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	658.50; 414.66	<0.001 sig
SECONDARY Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	5.11; 3.18	<0.001 sig
SECONDARY Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus	278.19; 274.46	<0.001 sig
SECONDARY Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions	73.4; 71.8; 5.9; 4.6; 48.8; 42.2	—
SECONDARY Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug	16.1; 12.6; 26.6; 16.4; 26.6; 16.2	—
SECONDARY Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug	16.1; 12.6; 26.6; 16.4; 26.6; 16.2	—
SECONDARY Percentage of Participants With Elevated Temperature by Severity	51.1; 64.3; 24.2; 19.1; 22.7; 15.5	—
SECONDARY Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion	0; 0.2; 0.2; 0; 0.1; 0.4	—
SECONDARY Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion	0; 0.2; 0.2; 0; 0.1; 0.4	—

Summary

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

Eligibility Criteria

Inclusion Criteria

Participant is a healthy infant
Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1 month of age

Exclusion Criteria

Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above
Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01337167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.